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FDA 510(k)

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER

K-Number: K982562 · 1998-12-28

ApplicantIntegrated Orbital Implants, Inc.
Decision Date1998-12-28
Product CodeHPZ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Orbital Implants, Inc.. It received FDA 510(k) clearance on 1998-12-28 under 510(k) number K982562. The device is classified under product code HPZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER?

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER is a medical device that received FDA 510(k) clearance on 1998-12-28. The listed applicant is Integrated Orbital Implants, Inc.. The 510(k) number is K982562.

When did BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER receive FDA 510(k) clearance?

BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER received FDA 510(k) clearance on 1998-12-28, under 510(k) number K982562.

Who is the listed applicant for BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER?

The FDA 510(k) record lists Integrated Orbital Implants, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER?

The FDA product code for BIO-EYE HYDROXYAPATITE OCULAR IMPLAND AND CONFORMER is HPZ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Integrated Orbital Implants, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003338BIO-EYE II ORBITAL IMPLANTK000151PERRY-KOLBERG (PK) HA-COATED TITANIUM SLEEVEK974203PERRY-KOLBERG (PK) TITANIUM MOTILITY/SUPPORT SYSTEMK891137MOTILITY ORBITAL IMPLANT

Related Devices (Code: HPZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212741EZYPORFci (France Chirurgie Instrumentation) SasK123764DURETTE OCULAR IMPLANTOculo-Plastik, Inc.K110554BIOCERAMIC ORBITAL IMPLANT, ORBTEXCeramisys, Ltd.K112176SILICONE SPHERESOculo Plastik, Inc.K083342ORBITAL RECONSTRUCTIVE IMPLANT IIEvera Medical, Inc.K082850EYE SPHERESProduct and Educational Services, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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